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Multiply Labs is revolutionizing cell therapy production with ai

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins.

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins, cutting costs by up to 70%, increasing throughput, and reducing contamination ri

The Biotech Times Editorial Team  · 
Pharmaceuticals

Menarini selinexor combo meets spleen endpoint in Phase 3 MF

Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Parabilis Medicines raises $745m in upsized Nasdaq IPO

The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
The Biotech Times Editorial Team  · 
Pharmaceuticals

J&J talquetamab plus daratumumab cuts RRMM death risk by up to 53%

Phase 3 MonumenTAL-3 data show talquetamab combinations beat standard care on PFS and OS in earlier-line relapsed myeloma.
Phase 3 MonumenTAL-3 data show talquetamab combinations beat standard care on PFS and OS in earlier-line relapsed myeloma.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

HUTCHMED sovleplenib hits Phase III primary endpoint in wAIHA

ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The Biotech Times Editorial Team  · 
Pharmaceuticals

Imviva Biotech wins FDA IND clearance for dual-target allogeneic CAR-T

CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
The Biotech Times Editorial Team  · 
Pharmaceuticals

BriaCell wins FDA clearance for Bria-BRES+ breast cancer IND

BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Tonix Pharmaceuticals gains GPO coverage for TONMYA across 35m lives

The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Idorsia shareholders back all board proposals at 2026 AGM

Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Novo Nordisk raises 2026 guidance as Wegovy pill tops 2m prescriptions

Novo Nordisk lifted its full-year outlook after Wegovy pill surpassed two million prescriptions since its January launch, despite US pricing pressure denting adjusted
Novo Nordisk lifted its full-year outlook after Wegovy pill surpassed two million prescriptions since its January launch, despite US pricing pressure denting adjusted
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%

Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Electra Therapeutics doses first patient in ipsoprubart T cell trial

Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
The Biotech Times Editorial Team  · 
Pharmaceuticals

Teva Q1 2026: AUSTEDO hits $578m as brands offset generics slide

Teva posted $4.0bn in Q1 revenues as AUSTEDO, AJOVY and UZEDY collectively grew 41%, cushioning a sharp fall in lenalidomide generics.
Teva posted $4.0bn in Q1 revenues as AUSTEDO, AJOVY and UZEDY collectively grew 41%, cushioning a sharp fall in lenalidomide generics.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Tonix Pharmaceuticals presents Phase 1 data for Lyme mAb TNX-4800

Tonix plans an adaptive Phase 2 field study of its anti-OspA monoclonal antibody in 2027, targeting a prevention gap with no approved U.S
Tonix plans an adaptive Phase 2 field study of its anti-OspA monoclonal antibody in 2027, targeting a prevention gap with no approved U.S
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Teva to acquire Emalex Biosciences for up to $900m in neuroscience bet

Teva will pay $700m upfront for Emalex and its NDA-ready D1 receptor antagonist ecopipam, targeting paediatric Tourette syndrome.
Teva will pay $700m upfront for Emalex and its NDA-ready D1 receptor antagonist ecopipam, targeting paediatric Tourette syndrome.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals

Tempest Therapeutics to present TPST-2003 CAR-T data at ISCT 2026

Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
The Biotech Times Editorial Team  · 
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